Lymphoma, Non-HodgkinPhase 2NCT00938041

Retreatment of Patients With Non-Hodgkin's Lymphoma Who Have Previously Responded to Iodine-131 Anti B1 Antibody

A Phase 2 study testing Tositumomab and Iodine I 131 Tositumomab in people with Lymphoma, Non-Hodgkin, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Lymphoma, Non-Hodgkin
What is being tested?: Tositumomab and Iodine I 131 Tositumomab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: No sites listed yet
Study dates: Apr 1998to Jun 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with histologically confirmed initial diagnosis of non-Hodgkin's B-cell lymphoma
Patients must have previously responded with a duration of response of at least 3 months to Iodine-131 Anti-B1 Antibody therapy
Patients must have evidence that their tumor tissue had CD20 expression
Patients must have performance status of at least 60% on the Karnofsky scale and an anticipated survival of at least 3 months
Patients must have absolute granulocyte count (ANC) greater than 1,500 cells/mm3 and platelet count greater than 100,000 cells/mm3 within 14 days of study entry without support of hematopoietic cytokines or transfusion of blood products
Patients must have adequate renal (serum creatine less than 1.5 x upper limit of normal) and hepatic function (total bilirubin less than 1.5 x upper limit of normal and hepatic transaminases, AST and ALT, less than 5 x upper limit of normal) within 14 days of study entry

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Patients must have bi-dimensionally measurable disease with a least one lesion greater than or equal to 2 cm x 2 cm by CT scan
Patients must be at least 18 years of age
Patients must give written informed consent and sign an Institutional Review Board/Ethics Committee- approved informed consent form prior to study entry

Who cannot join

Patients with more than 25% bone marrow involvement
Patients who have received cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry or who exhibit persistent clinical evidence of toxicity. The use of systemic steroids much be discontinued at least 1 week prior to study entry.
Patients with active obstructive hydronephoresis
Patients with evidence of active infection requiring IV antibiotics at time of study entry
Patients with New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation
Patients with prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for 5 years

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Patients with known HIV infection
Patients with known brain or leptomeningeal metasteses
Patients who are pregnant or nursing

About this study

Official title: Retreatment Study of Patients With Non-Hodgkin's Lymphoma Who Have Previously Responded to Iodine-131 Anti B1 Antibody

This multicenter study will determine the response rate, the complete response rate, duration of response, time to progression, time-to-treatment failure, safety, and survival following treatment with Iodine-131 Anti-B1 Antibody for the retreatment of patients with non-Hodgkin's lymphoma who previously responded with a duration of response of at least 3 months to Iodine-131 Anti-B1 Antibody therapy. Patients will undergo two phases of study. In the first phase, patients will receive a dosimetric dose of unlabeled Anti-B1 Antibody (450 mg) followed by Anti-B1 Antibody (35 mg) which has been radiolabeled with 5 mCi of Iodine-131. Whole body gamma camera scans will be obtained after the dosimetric dose and data from three imaging time points will be used to calculate a patient-specific dose to deliver the desired total body dose of radiotherapy. In the second phase, patients will receive the therapeutic dose of unlabeled Anti-B1 Antibody (450 mg) followed by 35 mg of Anti-B1 Antibody labeled with the patient-specific dose to deliver the desired whole body dose of radiation. Patients will be treated with thyroid blocking medication at least 24 hours prior to the first infusion and continuing for 14 days following the last infusion.

Conditions: Lymphoma, Non-Hodgkin
Being tested: Tositumomab and Iodine I 131 Tositumomab
Medical subject headings: Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tositumomab and Iodine I 131 TositumomabBiological
Tositumomab and Iodine I 131 Tositumomab

Study groups in NCT00938041
Study group	Role	What they receive
Retreatment of NHL with Iodine-131 Anti-B1 Antibody	Experimental	Patients with non-Hodgkin's lymphoma who previously responded with a duration of response of at least 3 months to Iodine-131 Anti-B1 Antibody therapy will undergo two phases of study. In the first phase, patients will receive a dosimetric dose of unlabeled Anti-B1 Antibody (450 mg) followed by Anti-B1 Antibody (35 mg) which has been radiolabeled with 5 mCi of Iodine-131. Whole body gamma camera scans will be obtained after the dosimetric dose and data from three imaging time points will be used to calculate a patient-specific dose to deliver the desired total body dose of radiotherapy. In the second phase, patients will receive the therapeutic dose of unlabeled Anti-B1 Antibody (450 mg) followed by 35 mg of Anti-B1 Antibody labeled with the patient-specific dose to deliver the desired whole body dose of radiation. Patients will be treated with thyroid blocking medication at least 24 hours prior to the first infusion and continuing for 14 days following the last infusion. Receives: Biological: Tositumomab and Iodine I 131 Tositumomab

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Complete Response and Confirmed Complete Response
Complete response (CR) is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Response is defined as the best response achieved at any evaluation. A confirmed response is defined as a response that was confirmed by two separate response evaluations occurring at least 4 weeks apart.
Measured: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)
Duration of Response for All Confirmed Responders (CR + CCR + PR)
For participants with CR, clinical CR (CCR), or partial response (PR), duration of response is defined as the time from the first documented response to the first documented progression. CCR is defined as the complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion <=2 centimeters (cm) in diameter by radiographic evaluation or <=1 cm in diameter by physical examination can be considered scar tissue. The extent of disease must be unchanged or decreased upon follow-up evaluations and, if unchanged or if further decreases for 6 months or longer are present, the participant will then be reclassified as a CR (complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease). PR is defined as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.
Measured: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)
Progression-free Survival
Progression-free survival (time to progression or death) is defined as the time from the start of retreatment (i.e., the dosimetric dose) to the first documented progression or death. Disease Progression (PD) is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be grater than 2 cm diameter by radiographic evaluation or grater than 1 cm diameter by physical examination.
Measured: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)
Time to Treatment Failure
Time to treatment failure is defined as the time from the dosimetric dose to the first occurrence of treatment withdrawal, a decision to receive additional therapy, study withdrawal, disease progression, or death.
Measured: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)
Overall Survival
Time to death (overall survival) is defined as the time from the start of retreatment (i.e., the dosimetric dose) to the date of death from any cause.
Measured: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)
Number of Participants With Any Serious Adverse Event (SAE) and Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; or resulted in disability, congenital anomaly, or cancer. Refer to the general AE/SAE module for a complete list of all AEs and SAEs.
Measured: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 1998Jun 2013

First posted13 Jul 2009 (estimated)
Study startApr 1998
Primary completionMay 2003
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00938041
Sponsor's protocol ID: 393229/010
Status last verified: Nov 2016
First submitted: 9 Jul 2009
Last updated: 9 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Retreatment Study of Patients With Non-Hodgkin's Lymphoma Who Have Previously Responded to Iodine-131 Anti B1 Antibody
ClinicalTrials.gov ID: NCT00938041
Acronym / sponsor ID: 393229/010
Conditions: Lymphoma, Non-Hodgkin
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Apr 1998
Primary completion: May 2003 (actual)
Study completion: Jun 2013 (actual)
First posted: 13 Jul 2009 (estimated)
Results: Posted 8 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Retreatment of NHL with Iodine-131 Anti-B1 Antibody	Experimental	Biological: Tositumomab and Iodine I 131 TositumomabPatients with non-Hodgkin's lymphoma who previously responded with a duration of response of at least 3 months to Iodine-131 Anti-B1 Antibody therapy will undergo two phases of study. In the first phase, patients will receive a dosimetric dose of unlabeled Anti-B1 Antibody (450 mg) followed by Anti-B1 Antibody (35 mg) which has been radiolabeled with 5 mCi of Iodine-131. Whole body gamma camera scans will be obtained after the dosimetric dose and data from three imaging time points will be used to calculate a patient-specific dose to deliver the desired total body dose of radiotherapy. In the second phase, patients will receive the therapeutic dose of unlabeled Anti-B1 Antibody (450 mg) followed by 35 mg of Anti-B1 Antibody labeled with the patient-specific dose to deliver the desired whole body dose of radiation. Patients will be treated with thyroid blocking medication at least 24 hours prior to the first infusion and continuing for 14 days following the last infusion.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Patients with histologically confirmed initial diagnosis of non-Hodgkin's B-cell lymphoma
Patients must have previously responded with a duration of response of at least 3 months to Iodine-131 Anti-B1 Antibody therapy
Patients must have evidence that their tumor tissue had CD20 expression
Patients must have performance status of at least 60% on the Karnofsky scale and an anticipated survival of at least 3 months
Patients must have absolute granulocyte count (ANC) greater than 1,500 cells/mm3 and platelet count greater than 100,000 cells/mm3 within 14 days of study entry without support of hematopoietic cytokines or transfusion of blood products

Key exclusion criteria (9 listed)

Patients with more than 25% bone marrow involvement
Patients who have received cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry or who exhibit persistent clinical evidence of toxicity. The use of systemic steroids much be discontinued at least 1 week prior to study entry.
Patients with active obstructive hydronephoresis
Patients with evidence of active infection requiring IV antibiotics at time of study entry
Patients with New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tositumomab and Iodine I 131 TositumomabTositumomab and Iodine I 131 Tositumomab	Biological	Retreatment of NHL with Iodine-131 Anti-B1 Antibody

Primary outcome

Number of Participants With Complete Response and Confirmed Complete Response
Time frame: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)
Complete response (CR) is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Response is defined as the best response achieved at any evaluation. A confirmed response is defined as a response that was confirmed by two separate response evaluations occurring at least 4 weeks apart.
Duration of Response for All Confirmed Responders (CR + CCR + PR)
Time frame: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)
For participants with CR, clinical CR (CCR), or partial response (PR), duration of response is defined as the time from the first documented response to the first documented progression. CCR is defined as the complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion <=2 centimeters (cm) in diameter by radiographic evaluation or <=1 cm in diameter by physical examination can be considered scar tissue. The extent of disease must be unchanged or decreased upon follow-up evaluations and, if unchanged or if further decreases for 6 months or longer are present, the participant will then be reclassified as a CR (complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease). PR is defined as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.
Progression-free Survival
Time frame: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)
Progression-free survival (time to progression or death) is defined as the time from the start of retreatment (i.e., the dosimetric dose) to the first documented progression or death. Disease Progression (PD) is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be grater than 2 cm diameter by radiographic evaluation or grater than 1 cm diameter by physical examination.
Time to Treatment Failure
Time frame: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)
Time to treatment failure is defined as the time from the dosimetric dose to the first occurrence of treatment withdrawal, a decision to receive additional therapy, study withdrawal, disease progression, or death.
Overall Survival
Time frame: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)
Time to death (overall survival) is defined as the time from the start of retreatment (i.e., the dosimetric dose) to the date of death from any cause.
Number of Participants With Any Serious Adverse Event (SAE) and Adverse Event (AE)
Time frame: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; or resulted in disability, congenital anomaly, or cancer. Refer to the general AE/SAE module for a complete list of all AEs and SAEs.

Results and safety

Results posted to the registry on 8 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab	32	5

Primary outcome: Number of Participants With Complete Response and Confirmed Complete Response

Time frame: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months). Number. Unit: Participants

Measure	Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab n = 32
Complete response	8
Confirmed complete response	8

Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab: percentage of participants: 25 (95% CI 10 to 40)
Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab: percentage of participants: 25 (95% CI 10 to 40)

Population analysed: ITT-Exposed Population: all participants who received at least one dose of study drug

Primary outcome: Duration of Response for All Confirmed Responders (CR + CCR + PR)

Time frame: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months). Median (95% Confidence Interval). Unit: Months

Measure	Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab n = 18
Value	18.9 (10.4 to 94.3)

Population analysed: ITT-Exposed Population. Only those participants with a confirmed CR, CCR, or PR were analyzed.

Primary outcome: Progression-free Survival

Measure	Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab n = 32
Value	11.9 (6.3 to 26.5)

Population analysed: ITT-Exposed Population. Participants who did not progress or die were censored at their date of last contact in the study.

Primary outcome: Time to Treatment Failure

Measure	Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab n = 32
Value	11.7 (6.0 to 21.4)

Population analysed: ITT-Exposed Population. Participants who withdrew from the study for reasons other than progression or death were censored at the date of study withdrawal. Participants who did not meet any of the criteria for treatment failure were censored at their date of last contact in the study.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab	18 of 32 (56.3%)	31 of 32 (96.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tositumomab and Iodine I 131 Tositumomab in people with Lymphoma, Non-Hodgkin, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Complete Response and Confirmed Complete Response (time frame: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00938041.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2017.